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FDA 510(k)

YO Home Sperm Test

K-Number: K161493 · 2016-11-08

ApplicantMedical Electronic Systems , Ltd.
Decision Date2016-11-08
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

YO Home Sperm Test is the device name listed in this FDA 510(k) record. The listed applicant is Medical Electronic Systems , Ltd.. It received FDA 510(k) clearance on 2016-11-08 under 510(k) number K161493. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YO Home Sperm Test?

YO Home Sperm Test is a medical device that received FDA 510(k) clearance on 2016-11-08. The listed applicant is Medical Electronic Systems , Ltd.. The 510(k) number is K161493.

When did YO Home Sperm Test receive FDA 510(k) clearance?

YO Home Sperm Test received FDA 510(k) clearance on 2016-11-08, under 510(k) number K161493.

Who is the listed applicant for YO Home Sperm Test?

The FDA 510(k) record lists Medical Electronic Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YO Home Sperm Test?

The FDA product code for YO Home Sperm Test is POV.

Other records listing Medical Electronic Systems , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243114SQA-iOw Sperm Quality AnalyzerK241628YO Home Sperm TestK220828SQA-iO Sperm Quality Analyzer

Related Devices (Code: POV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252228Seaman Pro/SeamanCheckcells, Inc.K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd.K242388LensHooke X12 PRO Semen Analysis SystemBonraybio Co., Ltd.K243114SQA-iOw Sperm Quality AnalyzerMedical Electronic Systems , Ltd.K241628YO Home Sperm TestMedical Electronic Systems , Ltd.K220828SQA-iO Sperm Quality AnalyzerMedical Electronic Systems , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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